Exploring Pathology Related to Slowly Expanding Lesions Using Advanced Imaging
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Финляндия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is an open, follow-up study to compare the performance of three critical imaging methods to detect chronic active lesions in Multiple Sclerosis (MS) in vivo.
Подробное описание
Smoldering inflammation is recognized as a critical contributor to MS progression-related central nervous system (CNS) damage. Activated microglia and macrophages particularly at chronic lesion edge are believed to promote lesion growth. Reversing their harmful activity may prove to be an efficient way to halt progression independent of relapses in MS.
These smoldering, or chronic active lesions can be detected in vivo using advanced imaging techniques. 1) Specific algorithms can be used to identify lesion growth, with a hypothesis that the slowly evolving lesions (SEL) are the ones harboring a rim of activated microglial cells, which contribute to damage in the surrounding tissue, and lesion growth. 2) Lesions partially or entirely surrounded by rims of increased tissue intensity on QSM-MRI (quantitative susceptibility mapping) sequences are considered as iron rim lesions, with iron-containing proinflammatory microglia/macrophages at the lesion edge. 3) In addition, 18 kDa translocator protein-positron emission tomography (TSPO-PET) imaging can be used to identify chronic active lesions based on TSPO-expression by activated innate immune cells, and their gathering at the edges of chronic active lesions. The TSPO-PET analysis of chronic active lesions can be semi-automated, and the specific radioligand binding at the chronic active lesion edge can be quantitated, which enhances the sensitivity of this method.
Despite existing preliminary data demonstrating increased QSM signal TSPO-positive lesions, it is yet to be demonstrated how these three imaging methods perform in identifying chronic active lesions when compared to each other at larger scale.
Первичные конечные точки
- Number of lesions [Срок оценки: 18 months, 36 months]
- Co-localization of lesions [Срок оценки: 18 months, 36 months]
Вторичные конечные точки (4)
- Correlation of PET imaging and clinical variables [Срок оценки: 18 months, 36 months]
- Correlation of magnetic resonance imaging and clinical variables [Срок оценки: 18 months, 36 months]
- Correlation of quality of life questionnaires and clinical variables [Срок оценки: 18 months, 36 months]
- Correlation of neuropsychological evaluation and clinical variables [Срок оценки: 18 months, 36 months]
Критерии участия
Критерии включения
- Signing the informed consent form
- MS diagnosis in accordance with McDonald 2017 criteria
- Available longitudinal brain MR images (minimum 1 year)
- Simultaneous QSM MRI sequence and TSPO-PET
- Lesions with iron rim/s
Критерии исключения
- Patients with other neurodegenerative disease than MS
- Patients with other autoimmune disease than MS
- Patients with other significant or malignant underlying disease of any other organ system
- Patients that are pregnant or breast-feeding
- Corticosteroid treatment within 4 weeks of imaging
- Patients with significant abnormal findings other than MS in the screening MRI
- Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
- Contraindication to PET scan investigations
- Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study
- Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Финляндия · 1 центр
- Turku PET Centre — Turku
Идентификаторы
NCT: NCT06460077 · SELPET